LUNA18 for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Cancer Center Hospital East, Kashiwa, Japan
Cancer+1 More
LUNA18 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new drug called LUNA18 is safe and effective in treating cancer.

See full description

Eligible Conditions

  • Cancer
  • Metastatic or Locally Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cancer

Study Objectives

This trial is evaluating whether LUNA18 will improve 8 primary outcomes and 5 secondary outcomes in patients with Cancer. Measurement will happen over the course of From Cycle 0 Day 1 (Cycle 0 is 6-9 days) until study completion or treatment discontinuation (up to approximately 43 months).

Month 43
Anti-drug antibody to LUNA18 [Part A, B and C]
Area under the concentration versus time curve (AUC) of LUNA18 [Part A]
Maximum plasma concentration (Cmax) of LUNA18 [Part A]
Plasma concentrations of LUNA18 [Part A]
Plasma concentrations of LUNA18 [Part B and C]
Safety and tolerability of LUNA18 (Adverse Events) [Part A, B and C]
Time to reach maximum plasma drug concentration (Tmax) of LUNA18 [Part A]
Day 28
Safety and tolerability of LUNA18 (Dose-limiting toxicities) [Part A]
Month 43
Preliminary anti-tumor activity of LUNA18 [Part A, B and C]
Preliminary anti-tumor activity of LUNA18 [Part A]
Preliminary anti-tumor activity of LUNA18 [Part C]
Month 43
Phosphorylation level of ERK protein (pERK) in tumor tissues [Part A and C]
Phosphorylation level of ERK protein (pERK) in tumor tissues [Part B]

Trial Safety

Safety Progress

1 of 3

Other trials for Cancer

Trial Design

3 Treatment Groups

Cohort expansion part (Part C)
1 of 3
Biomarker part (Part B)
1 of 3
Dose escalation part (Part A)
1 of 3
Experimental Treatment

This trial requires 195 total participants across 3 different treatment groups

This trial involves 3 different treatments. LUNA18 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Cohort expansion part (Part C)
Drug
Patients will receive LUNA18 capsule(s) at the recommended dose
Biomarker part (Part B)
Drug
Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A
Dose escalation part (Part A)
Drug
Patients will receive LUNA18 capsule(s) at escalated doses

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible for reporting.

Closest Location

NEXT Oncology - Austin, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer or the other condition listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age >= 18 years at time of signing informed consent form
ECOG performance status of 0 or 1
Patients with a histologically or cytologically proven diagnosis of a locally advanced, recurrent, or metastatic incurable solid tumor for which standard therapy either does not exist or has proven ineffective or intolerable
Patients with documented RAS alterations positive solid tumors
Patients with measurable disease per RECIST v1.1

Patient Q&A Section

Can cancer be cured?

"1. The cure can be defined as a disease that has been cured.\n2. The cure should be defined by a cancer that has been cured according to the definition set by the world health organization.\nImage source: Cure for cancer\n\nThe first issue to arise is: Is cure for cancer a true cure. Some people will say that the cure for cancer is no longer in danger of death. And those who said otherwise have not had an experience of a true cure for cancer. A cure for cancer that is said to be truly permanent is the ultimate goal of all of the researchers." - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"The cause of cancer is complicated, but it can be divided into categories which help to understand cancer. Smoking is a major risk factor for cancer." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"The most common treatments for cancer are surgery, radiation, and medications. Patients should receive education about these treatments and know what they may entail for them in terms of what the chances of survival or remission are." - Anonymous Online Contributor

Unverified Answer

How many people get cancer a year in the United States?

"Between 2000 and 2010, an annual increase of 11.6% was found in the annual estimates of diagnosis with skin cancer, lung cancer, and breast cancer." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"Cancer is a type of disease that causes abnormal cell growth of tissue that leads to the spread of cancer cells. It often starts with benign lesions that grow to become cancerous. There are many types of cancer, such as lung cancer, breast cancer, colon cancer and more.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"There are several signs and symptoms of cancer that are most probably associated with metastases. The early identification of these signs may give clinicians an advantage in deciding the best adjuvant regimen." - Anonymous Online Contributor

Unverified Answer

Does cancer run in families?

"It seems the incidence rate of breast or [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is increasing among the older people. The risk and type of cancer vary depending on the type and site of the tumours of family members. A risk-factor study, as well as studies of genetic markers such as BRCA1 and BRCA2, will be helpful in developing new strategies for early diagnosing and treating breast and prostate cancers in families." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of luna18?

"Luna18 (an injectable interferon-2a, marketed as LunaCare in China) is a medication used in the treatment of certain types of cancers. While there is only limited research data on its side effects, our study shows these side effects do occur and they can have a huge impact on a patient's quality of life. This is especially the case for patients who are currently treated with other drugs for their condition." - Anonymous Online Contributor

Unverified Answer

Is luna18 typically used in combination with any other treatments?

"Luna18 was used in combination with any of these treatment modalities. Both platinum- and paclitaxel-containing regimens have been successful. Luna18 appeared to be effective in the salvage chemotherapy setting in our patient population and for patients with refractory solid tumors. Data from a recent study indicate that Luna18 is a treatment that has been studied and is safe and effective in patients with multiple types of cancer. The study is small and additional data will need to be gathered to confirm these results." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cancer?

"We are at the crossroads of the development of the latest anticancer drugs, new therapeutic tools, and diagnostic technologies related to cancer management, as well as the development of new research methodologies to answer all the questions and to formulate a new strategy of chemotherapy in the treatment of cancer patients in the era of anticancer drugs." - Anonymous Online Contributor

Unverified Answer

How serious can cancer be?

"One need not be a specialist to realise the seriousness of any cancer condition. A basic understanding of its prevalence and its clinical manifestations, however, is worthwhile. At a national level, this information will assist authorities to establish a cancer prevention policy, set up more comprehensive cancer control programs and to create a cancer registry." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving luna18?

"luna18 is currently in study to test its effectiveness on patients with cancer. More data are needed regarding its safety/efficacy/tolerability profile before its broad-scale application." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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